Cystic Fibrosis Related DiabetesPhase 3NCT00222521
Insulin Glargine Vs Standard Insulin Therapy
A Phase 3 study testing Glargine insulin in people with Cystic Fibrosis Related Diabetes, run by University of Minnesota at 1 site in United States.
Trial summary
This Study is designed to determine whether treatment of CFRD with glargine insulin will improve hemoglobin A1c, weight and muscle mass compared to the traditional regimen of bedtime NPH insulin. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis Related Diabetes
- What is being tested?
- Glargine insulin
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Aug 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Inclusion Criteria
- CFRD with fasting hyperglycemia (fasting plasma glucose ≥126 mg/dl)
- . The diagnosis must be made at a time when the patient is in his/her basal state of health with no evidence of acute exacerbation in the preceding two months. a). Acute exacerbation is defined on page 9.
- . For patients with onset of diabetes in the preceding 6 months, the hemoglobin A1c must be stable for 3 months prior to study entrance within 5% (0.3% A1c increment).
- Age ≥18, post-pubertal (done growing, since change in weight is a study endpoint)
- Weight stable within 5% during the previous 3 months as measured in CF clinic
- Willingness to attend all study visits and to engage in regular phone or e-mail contact with the study diabetes nurse
- Glucocorticoids can have a profound effect on weight, and thus we wish to minimize the occurrence of changing steroid doses during the study period. Patients receiving glucocorticoid therapy will be included in the protocol only if:
- . They have been on the same steroid dose for the preceding six months,
- . There are no plans to change their steroid dose in the next eight months.
- Exclusion Criteria
- Pregnancy or plans to become pregnant in the next eight months (because of the changes pregnancy would cause in our study endpoints),
- Unwillingness / inability to take multiple injections or to count carbohydrates,
- A history of hypoglycemia unawareness (rare in CF),
- Plans to start any medication in the next 8 months that might affect weight, such as testosterone or Megace. Patients chronically taking these medications may be included if:
- . They have been on the same dose for the preceding six months
- . There are no plans to change their dose in the next eight months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Comparison of Insulin Glargine Vs Standard Insulin Therapy in CFRD Without Fasting Hyperglycemia
This Study is designed to determine whether treatment of CFRD with glargine insulin will improve hemoglobin A1c, weight and muscle mass compared to the traditional regimen of bedtime NPH insulin.
Read the detailed description
The majority of cystic fibrosis (CF) patients now survive beyond childhood, and CF related diabetes (CFRD), due to insulin deficiency, is common. CFRD with fasting hyperglycemia occurs in about 15% of adult CF patients. Standard insulin therapy has relied primarily on meal coverage with rapid-acting insulin. Usually, basal insulin coverage is only provided overnight, with modest doses of NPH insulin. The practice of providing minimal basal insulin in CFRD is based on the fact that most of these patients, unless they are acutely ill, are able to maintain relatively normal blood glucose levels during the day without it. In addition, anecdotal experience has suggested that daytime NPH insulin or once to twice daily ultralente insulin frequently lead to hypoglycemia in the CFRD patient. This practice, which is based on practical clinical considerations, ignores the established relationship between insulin deficiency and clinical deterioration in CFRD. BMI and pulmonary function deteriorate much more rapidly in CF patients with diabetes than in CF patients with normal glucose tolerance. Insulin deficiency leads to increased protein catabolism and fatty acid turnover. The resulting loss of weight and lean body mass contributes to pulmonary disease and clinical decline.
We hypothesize that:
- Basal insulin coverage with insulin glargine will improve hemoglobin A1c, weight, and muscle mass in patients with CFRD with fasting hyperglycemia, compared to traditional regimens with less basal insulin.
- Because of the peakless action of insulin glargine, this will be accomplished without serious hypoglycemia.
- Conditions
- Cystic Fibrosis Related Diabetes
- Being tested
- Glargine insulin
- Keywords
- Cystic Fibrosis, Diabetes
- Medical subject headings
- Cystic Fibrosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glargine insulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Secondary outcomes (4)
BMI
Body composition by DEXA Scan
# Episodes of illness
Quality of life survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis Related DiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Moran, Antoinette, M.D.
- Investigators
- Antoinette Moran, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222521
- Sponsor's protocol ID
- 0205M25461
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Insulin Glargine Vs Standard Insulin Therapy in CFRD Without Fasting Hyperglycemia
- ClinicalTrials.gov ID
- NCT00222521
- Acronym / sponsor ID
- 0205M25461
- Conditions
- Cystic Fibrosis Related Diabetes
- Keywords
- Cystic Fibrosis, Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Sanofi, Moran, Antoinette, M.D.
- Study start
- Apr 2003
- Study completion
- Aug 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Study is designed to determine whether treatment of CFRD with glargine insulin will improve hemoglobin A1c, weight and muscle mass compared to the traditional regimen of bedtime NPH insulin.
Detailed description
The majority of cystic fibrosis (CF) patients now survive beyond childhood, and CF related diabetes (CFRD), due to insulin deficiency, is common. CFRD with fasting hyperglycemia occurs in about 15% of adult CF patients. Standard insulin therapy has relied primarily on meal coverage with rapid-acting insulin. Usually, basal insulin coverage is only provided overnight, with modest doses of NPH insulin. The practice of providing minimal basal insulin in CFRD is based on the fact that most of these patients, unless they are acutely ill, are able to maintain relatively normal blood glucose levels during the day without it. In addition, anecdotal experience has suggested that daytime NPH insulin or once to twice daily ultralente insulin frequently lead to hypoglycemia in the CFRD patient. This practice, which is based on practical clinical considerations, ignores the established relationship between insulin deficiency and clinical deterioration in CFRD. BMI and pulmonary function deteriorate much more rapidly in CF patients with diabetes than in CF patients with normal glucose tolerance. Insulin deficiency leads to increased protein catabolism and fatty acid turnover. The resulting loss of weight and lean body mass contributes to pulmonary disease and clinical decline.
We hypothesize that:
- Basal insulin coverage with insulin glargine will improve hemoglobin A1c, weight, and muscle mass in patients with CFRD with fasting hyperglycemia, compared to traditional regimens with less basal insulin.
- Because of the peakless action of insulin glargine, this will be accomplished without serious hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glargine insulin | Drug | – |
Primary outcome
Hemoglobin A1c
4 secondary outcomes
BMI
Body composition by DEXA Scan
# Episodes of illness
Quality of life survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoinette Moran, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glargine insulin in people with Cystic Fibrosis Related Diabetes, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2005.